The global pharmaceutical aseptic transfer market was valued at USD 937 million in 2022. It is estimated to reach USD 2,141 million by 2031, growing at a CAGR of 9.61% during the forecast period (2023–2031).
The pharmaceutical aseptic transfer system aid in the aseptic transfer of drugs and other pharmaceutical products across the drug development cycle, i.e., from research and development to packaging and distribution. The requirements for maintaining an aseptic environment during the development stage have always existed in the pharmaceutical sector, but they have grown more strict over time, particularly in the case of high-potency medications.
The global pharmaceutical aseptic transfer market players offer various types of products for aseptic transfer, such as isolators, restricted access barrier systems (RABS), laminar airflow (LAF) trolleys, portbags, rapid transfer ports, sterile connectors, and tubings. Players in the market are focused on aligning their product portfolios with the current market trends, such as using single-use technology (SUT) systems. Aseptic sampling can be used to manufacture drugs of high quality.
The pharmaceutical business has seen tremendous growth over the last few years, and it is projected that this growth will continue over the forecast period. The increasing prevalence of diseases leading to an increased patient pool, the growing affordability of drugs, and the rising focus of government authorities to enhance pharmaceutical facilities is leading to the expansion of the pharmaceutical industry globally.
The production of pharmaceutical drugs requires an aseptic medium to prevent contamination in the process. Contamination in pharmaceutical facilities can affect the quality of drugs and can compromise patients' safety. Therefore, aseptic manufacturing of pharmaceutical products plays a significant role in preventing contamination. In addition, aseptic transfer systems are used in the sterile transfer of APIs and formulation ingredients during aseptic processes. They help prevent contamination of components, preventing infections in patients. Moreover, expanding the pharmaceutical industry leads to increased adoption of aseptic systems, thereby propelling the market's growth.
Increased aseptic pharmaceutical transfer equipment automation is expected to boost efficiency, reduce housekeeping costs, eliminate costly safety and ergonomic issues, and cut down on ingredient expenditures. Manufacturers are looking for cost-effective alternatives to produce aseptic pharmaceutical products to fulfill the rising demand due to the rising labor cost. Along with technological advancement, customers also expect companies to focus on cost reductions rather than passing on rising costs.
Automated systems can reduce costs by increasing productivity, solving price, safety, and hygiene-related problems, adding flexibility to lines, and eliminating product contamination and other issues. In addition, the pharmaceutical industry is increasingly using robotics to automate specific processes in drug development, including drug screening, anti-counterfeiting, and manufacturing tasks.
Aseptic transfer processes are incredibly complicated and require a significant capital investment. The technology and equipment needed for aseptic transfer involve a substantial price and significant depreciation risk. Setting up the aseptic pharma transfer equipment is a one-time process with a shelf life of a minimum of ten years. However, the equipment and systems cost is high, which restricts many pharmaceutical manufacturers from setting up an in-house aseptic transfer system. Moreover, once the aseptic transfer systems are installed, they need constant maintenance. The single-use bags used for aseptic transfer also has a high cost. Therefore, the high price of aseptic processing equipment restricts many buyers and forces them to go with the conventional terminal sterilization method, hampering the growth of the pharmaceutical aseptic transfer market.
The revolution across all industries for data utilization has become an opportunity for the aseptic pharmaceutical sector. This opportunity has led to the origin of the "smart factory" concept that allows pharmaceutical companies to view the usage of data analysis within the processing lines. The smart factory concept has several advantages, including maintaining the health of all aseptic processing. The information provides significant assistance in remote working scenarios as it generates real-time data that can help the operatives determine the exact time and situation when maintenance is required for processing, offering an intervention before the crisis, therefore, maintaining productivity and functional integrity of the aseptic process.
There is a significant opportunity to acquire and link data at exceptional levels. This data can be used to build a better model, predict and control the aseptic processes in the facility, and make a better plan for them. Furthermore, virtual reality and simulation can also be used in the aseptic industry to shape the facilities, strategize and address difficulties in simulation without putting the actual plant operations at risk, and provide more effective staff training, thereby creating opportunities for the market to grow.
The global pharmaceutical aseptic transfer market is segmented by system type, transfer type, usability, and end-user.
By system type, the global market is divided into solid and liquid transfer systems.
The solid transfer system segment is responsible for the largest market share and is anticipated to grow at a CAGR of 9.15% over the forecast period. Traditionally, handling bulk solid materials such as pharmaceutical powders was associated with various challenges, such as single bag openings that made dispensing difficult, the additional requirement of rinse lines to ensure the transfer of all the particles, and non-reliable films that were prone to breakage if dropped. However, innovations surrounding solid bulk transfer have overcome these challenges to a large extent. Some global pharmaceutical aseptic transfer markets players, such as ILC Dover LP and Dec Group, offer innovative solutions for the aseptic transfer of powders. For instance, ILC Dover LP offers EZ BioPac to facilitate easy filling, weighing and transferring of powders in a sterile environment.
The conventional systems consisting of stainless-steel bioreactors pose various challenges concerning their cleaning and sterilization. In contrast, single-use systems are increasingly becoming the preferred choice of liquid transfer. Getinge AB offers the single-use DPTE-BetaBag as an aseptic liquid transfer solution for the pharmaceutical industry. The bag can be used with other components, such as the DPTE rapid transfer port (RTP), tubings, and connectors, to enable the sterile transfer of liquids between the DPTE-BetaBag and a containment system, such as an isolator.
By transfer type, the global market is segmented into ports, portbags, and others.
The other segment owns the highest market share and is expected to grow at a CAGR of 8.92% over the forecast period. The other segment consists of isolators, accessories, transfer carts, tubing caps, bio containers, and bioprocessing. Aseptic isolators are closed barrier system used for sterile manufacturing that provides a closed and sterile grade-A aseptic environment for fill finfish activities requiring positive and negative pressure. Pharmaceutical companies can use it in various applications such as powder transfer, powder weighing, and reactor loading. Laminar flow trolleys are mobile transport carts or trolleys. These laminar flow trolleys eliminate contamination while transferring sterile/aseptic materials.
Portbags are used for the aseptic transfer of components into clean rooms, and isolators RABS for the contained transfer of materials. They are made of high-grade plastics that are autoclavable or gamma-sterilizable. It is manufactured using a combination of Tyvek and high-density polyethylene plastic (HDPE).
By usability, the global market is segmented into single-use and multiple-use.
The single-use is the highest contributor to the market and is anticipated to grow at a CAGR of 10.16% over the forecast period. The rising demand for single-use components is one of the key trends shaping the global pharmaceutical aseptic transfer market. Conventional systems were exposed to challenges such as extensive and time-consuming cleaning and sterilization processes, environmental pollution, and energy consumption. The advent of sterile single-use technologies (SUT) overcame these challenges to a large extent, thereby marking a definitive transformation in the pharmaceutical industry. Aseptic connectors, sterile bio containers, and bioprocess bags are vital examples of SUT systems. The key advantages of single-use systems for the aseptic transfer include reduction of environmental impact, cost saving, and significantly higher sterility assurance.
Multiple-use systems such as stainless-steel equipment are more commonly used for large-scale applications where a high volume of the product is desired. Therefore, economies of scale are a crucial advantage of multiple-use systems. Multiple-use systems are the preferred type for downstream processing in the biopharmaceutical industry owing to multiple recycling steps applied to purification systems such as columns or resins.
By end-user, the global market is divided into pharmaceutical companies, contract development and manufacturing organizations (CDMOs), and others.
The pharmaceutical company segment owns the highest market share and is estimated to grow at a CAGR of 8.92% over the forecast period. The pharmaceutical industry is highly regulated, with stringent guidelines surrounding the manufacture and processing of drugs and other pharmaceutical products. Therefore, maintaining sterility and an aseptic environment is of utmost importance to ensure the production of drugs of high quality and potency. Thus, drug manufacturers rely on companies offering aseptic systems for the pharmaceutical industry.
Contract development and manufacturing organizations (CDMOs) assist pharmaceutical companies throughout drug development, from manufacturing to commercialization. The trend of rising demand for single-use systems is also observed with CDMOs. CDMOs that partner with different pharmaceutical companies is required to switch production efficiently and quickly from one drug to another. In that respect, single-use systems are valuable as they allow instant shifts in production without requiring extensive cleaning and sterilization steps.
By region, the global pharmaceutical aseptic transfer market is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global pharmaceutical aseptic transfer market shareholder and is anticipated to grow at a CAGR of 10.35% during the forecast period. One of the main reasons for the market growth in North America is that the pharmaceutical industry is very technologically advanced. The various critical developments in the U.S. are another key factor propelling the market growth. The U.S. has several established pharmaceutical companies engaged in research and development and manufacturing innovative drugs. In addition, the U.S. has witnessed several key developments in the market in the past few years, such as increasing investment to expand manufacturing facilities for parenteral drugs and single-use systems (SUS) for the aseptic processing of drugs.
Europe is estimated to grow at a CAGR of 9.87% over the forecast period. The growth in the pharmaceutical industry, the growing awareness regarding sterile manufacturing of drugs, and the implementation of stringent regulations for the drug approval process are some of the key factors driving the market growth in Europe. Investments by various pharmaceutical companies to expand manufacturing facilities to boost production are witnessed in Europe. In addition, the region has companies offering solutions for the aseptic transfer of pharmaceuticals, such as barrier systems, connectors, and sterile bioprocess bags.
The Asia-Pacific region consists of many emerging economies undergoing significant technological advancements and improvements in their pharma sector. The region has many countries with high potential for scientific achievement, particularly in pharmaceuticals. The Asia-Pacific region's low- and middle-income countries are witnessing a constant increase in the incidence of various genetic disorders. Additionally, several companies are expanding their API manufacturing sites to the region, propelling the market's growth. For instance, in June 2022, WuXi AppTec established a high-potency active pharmaceutical ingredient (HPAPI) production facility in China. The pharmaceutical aseptic transfer market in the Asia-Pacific represents one of the most attractive markets worldwide and is growing exponentially.
The Latin American pharmaceutical aseptic transfer market is still in its intermediary phase. Several major drug firms acquired companies in Latin America during 2010-2020. For instance, in February 2012, Merck & Co. took a 51% stake in a joint venture with Brazil's Supera Farma Laboratories. The demand for aseptic pharma processing equipment is anticipated to increase due to the increase in the production capacity of the region.
The Middle East and Africa have witnessed various pharmaceutical companies expanding their manufacturing facilities to boost regional production. For instance, the United Arab Emirates (U.A.E.) plans to build a global hub for different international pharmaceutical companies and increase its manufacturing facilities. Furthermore, the U.A.E. Ministry of Health and Prevention and Jafza, a D.P. world company, has signed an agreement to develop the healthcare and pharmaceutical segment in the country. Under the agreement, the U.A.E. Ministry of Health and Prevention and Jafza planned to register more than 75 significant pharmaceuticals globally. Such factors are expected to propel regional market growth.
The key players in the global pharmaceutical aseptic transfer market are
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